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Tuesday, April 12, 2011

Foolus Cleared by the FDA

Fellow bloggers, one of TSB favorite quotes is " the difference between truth and fiction is, fiction only has to make sense." Especially, when you are pandering to potential investors weaknesses. For a company whose stock dropped from an all time high of $7.62 and today hovers around $2.95 there's a sense of urgency at AlphaWreck. On April 11th, the FDA, you know, better known as the spine industry's boogie man, approved the Solus. Now there's marketing ingenuity at its best, an original name, if ever used in our industry. Solus means to stand alone, so does this mean that the Solus will be a stand alone device? In addition, this device is touted as a innovative interbody. As the Family Guy would say, WTF? But it gets funnier when one scrolls down through the article posted on OTW. This device has counter rotating blades, ooooooh!

But here's the kicker, Dirk Kuyper is quoted as saying, "in order to optimize the success of this REVOLUTIONARY PRODUCT, the controlled launch will be a tiered release with emphasis on both clinician and sales training." You aren't serious? Surgeons and sales reps will need to be trained on how to activate rotating blades. TSB would think that at this juncture most surgeons understand how to approach the disc space, or course unless you're one of the surgeons that spends more time in litigation than in operation, or you can't read an MRI, CT or X-Ray. So in closing, TSB wants to know what our fellow bloggers believe, is this new, is this true and will this make a difference?

You know what the Maestro Eric Clapton once sang;

If I could reach the stars, pull one down for you
Shine it on my heart, so you could see the truth
That this love I have inside, is everything it seems
As for revolutionary innovation, it's all in your dreams
That I could change the world, I would be the solus in your universe....

29 comments:

I saw the press release last week and I'm wondering if this actually is cleared as a "Stand-Alone" device. Looking at the design, seems like there's a sacrifice of graft space, requiring the surgeon to funnel in the remaining graft after implantation, too. Didn't Theken come out with a similar device with a spin plate a few years back? Great for an internal butress, but come on. WTF? Will the blades be activated like the throwing star in the low budget 1980's film Krull? It's telekenisis Kyle!

I saw this device and it's nothing special. Once the cage is inserted, the surgeon turns a nut on the front of the cage and blades dig into the superior and inferior end plates. The mechanism takes up a bunch of graft space and cuts with curved knife edge blades. This will do nothing for this sinking ship of a company. The only way to make money with AlphaWreck is to short their stock. I wonder how all the surgeons that were allowed to buy in at $9/share before the IPO feel now?

I wouldn't be so quick to discount this product. Zero profile interbody spacers are here to stay. Although its certainly not revolutionary and most surgeons are capable of implanting it without training. One of the biggest benefits that I can see is that it has a much safer revision strategy. Unlike the LDR's (corpectomy), this appears to be much more revision "friendly". Also safer as less passes of otherwise sharp screws and associated instruments.

Novel, sure. Revolutionary, not so much. Biomechanical data will be the judge on this device's stability versus a stand alone with screws. If it passes muster, good for them. If not, it will be too expensive to use with an anterior plate.

TSB, kinda unlike you to pick on a product release. I'm not sure this is blogworthy. I haven't heard that ATEC is relying on this to make any big turnaround. It seems they put more emphasis on Puregen than they have on Solus. Any Puregen sales being seen out there?

PODs, owners of a POD, a girlfriend rep, a SPINE surgeon along with references to a document indicating a LA surgeon was paid over half a million by a POD for the suegeon's implant usage IS ON THE COVER OF THE WALL STREET JOURNAL TODAY! The surgeon!s OR privileges are suspended.

Maybe a few stem cell products such as Puregen may make some headway. I've seen no data that suggests that Puregen is more beneficial. As for the Solus, if the graft area requires a funnel, it's just like passing a few screws regarding sharp instruments. A screw system at least has drill/tap where you may have to torque the plates to cut into the endplates. I can see some poor sureon over torquing and slips the instrument out. Where does it go? Use your imagination.

The dates don't match gents. He was using Stryker when he commited these revisions. I guess that makes PODS still the enemy in your eyes even though they were in no way involved. Check the first article about Dr. Makker in the WSJ. The dates of these surgeries were between 2004-2010!!! Now who do you blame?? Stryker, Alphatek, PODs, Depuy, my brother in law??.....Dr. Makker, who drives a sporty black Mercedes with "J MAK" vanity plates, attended medical school at the University of Texas Health Science Center in San Antonio and did his neurosurgery residency at Rhode Island Hospital in Providence. When he completed his training in 2002, he moved to Portland. Dr. Makker quickly built a busy surgical practice. By July 2005, his net worth was $8.7 million, according to a document filed in court when he and his wife divorced in 2008. Dr. Makker estimated in a legal deposition in a separate proceeding that he performs between 300 and 500 spinal surgeries a year. The Medicare data show that Dr. Makker performed seven separate spinal fusions on one patient in less than two years. Dr. Makker said the patient, who wasn't identified in the data, was "an extremely complicated and difficult" case, compounded by several device failures and by the fact that the patient was a heavy smoker, which he said impaired healing.Five more Medicare patients had three separate spinal fusions performed by Dr. Makker, the data show.Leo Hamilton, too, had his spine operated on by Dr. Makker seven times. Mr. Hamilton mentioned the surgeries in a lawsuit unrelated to his medical care—a suit against Gresham, a small city east of Portland,claiming that police officers injured his neck when they arrested him following a shooting in 2005.Dr. Makker had operated on Mr. Hamilton's spine three times prior to the incident, and he did four more operations afterward. In a videotaped deposition for the lawsuit, Dr. Makker acknowledged that the seven surgeries, for which he personally billed about $175,000, did nothing to improve Mr. Hamilton's condition.Dr. Makker faced his first malpractice suit in 2005. In a videotaped deposition for the lawsuit, Dr. Makker acknowledged that the seven surgeries, for which he personally billed about $175,000, did nothing to improve Mr. Hamilton's condition.All told, Dr. Makker has settled four cases for a total of more than $1.2 million. He said he cannot comment about the settled cases because of confidentiality agreements. He prevailed at trial in a fifth case, and a sixth case was dropped by the plaintiff. Two more suits were filed recently by female patients and are pending. One of the women said she was operated on by Dr. Makker five times in less than 13 months, and the other said she had three operations in less than five months.

If anyone at ATEC was confident in marketing to have the user requirements right from the start and the ability to have the field primed/trained for the launch, then they would take the risk, build the sets, and do a real launch.

Every company does a limited or controlled launch with a product, but for most, it's considered a final validation and they are already committed to a real launch date usually 3 to 6 months after.